The invention is directed to systems and methods for monitoring and controlling use of medical devices.
Use of medical devices intended to treat or diagnose conditions of the body can sometimes generate stress on the material or materials from which the devices are made. The material stress can alter the physical characteristics of the devices, making future performance of the devices unpredictable.
In addition, exposure to blood and tissue during use can entrap biological components on or within many medical devices. Despite cleaning and subsequent sterilization, the presence of entrapped biological components can lead to unacceptable pyrogenic reactions.
The effects of material stress and damage caused during a single use of a medical device, coupled with the possibility of pyrogen reactions even after resterilization, reasonably justify imposing a single use restriction upon many medical devices.
The invention provides systems and methods for monitoring and controlling use of medical devices. The systems and methods employ a controller to control operation of the device and a reader to download information to the controller. The systems and methods also include a usage key card adapted to be handled separate from the device and comprising a storage medium formatted to contain an identification code unique to the usage key card. Upon reading by the reader, the identification code is downloaded to the controller. The controller includes a processing function for processing the identification code to either enable or disable operation of the device according to prescribed criteria. The systems and methods further include a display screen and an operating system to generate a viewable image on the display screen that changes in response to processing of the identification code by the processing function.
In one embodiment, the processing function causes the controller to create a table by registering unlike identification codes in memory as they are downloaded by the reader. The controller enables operation of the device when a new identification code is registered in the table. In this arrangement, the operating system displays a first image to prompt input to create the table for the device using the processing function.
In one embodiment, the processing function causes the controller to disable operation of the device when the given identification code matches an identification code in the table. In this arrangement, the operating system displays a second image, different than the first image, to prompt exchange of the device when operation of the device is disabled as a result of the processing function.
In one embodiment, the processing function causes the controller to register in the table, a time period of use of the device. In this arrangement, the processing function causes the controller to disable operation of the device when the time of use exceeds a prescribed period. The operating system displays a second image, different than the first image, to prompt exchange of the device when operation of the device is disabled as a result of the processing function.
In one embodiment, the device applies radio frequency energy to the tissue region.
Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended Claims.